Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer

NCT04187898 | Completed Phase 1 FDA Drug

• 1 other identifier: SPI-GCF-104
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to compare the effect of Eflapegrastim on duration of neutropenia in patients with early-stage breast cancer when administered at varying intervals following Docetaxel and Cyclophosphamide administration.

Conditions

Neutropenia; Breast Cancer

Keywords

Neutropenia; Early Stage Breast Cancer; Long-acting Myeloid Growth Factor; Docetaxel + Cyclophosphamide (TC) Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Time to Recovery of Absolute Neutrophil Count (ANC) From Nadir to ≥1.5×10^9/L in Cycle 1

  Time to ANC Recovery is defined as the time from chemotherapy administration until the patient's ANC increases to ≥1.5×10\^9/liter (L) after the expected nadir.

  Cycle 1 is 21 days

Secondary Outcomes (11)

• Duration of Grade 4 Neutropenia (DSN) in Cycle 1

  Cycle 1 is 21 days

• Proportion of Patients With Grade 4 Neutropenia in Cycle 1

  Cycle 1 is 21 days

• Incidence of Grade 3 Febrile Neutropenia (FN) in Cycle 1

  Cycle 1 is 21 days

• Incidence of Neutropenic Complications, Including Hospitalization due to Neutropenia, FN, and use of Anti-infectives During Cycle 1

  Cycle 1 is 21 days

• Expansion Phase: Time to Recovery of ANC From Nadir to ≥1.5×10^9/L in Cycles 2-4

  Cycles 2-4 (cycle length=21 days) (up to approximately 63 days)

Study Arms (4)

Early Phase: Eflapegrastim @ 30mins post TC

EXPERIMENTAL

Eflapegrastim (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg granulocyte colony-stimulating factor \[G-CSF\]). Supplied in prefilled single-use syringes for subcutaneous injection. Cycle 1: Administered on the same day as TC chemotherapy, 30 minutes from the end of TC administration. Cycles 2-4: Administered 24 hours after TC chemotherapy administration. Each cycle is 21 days.

Biological: Eflapegrastim; Drug: Docetaxel; Drug: Cyclophosphamide

Early Phase: Eflapegrastim @ 3 hours post TC

EXPERIMENTAL

Eflapegrastim (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg G-CSF). Supplied in prefilled single-use syringes for subcutaneous injection. Cycle 1: Administered on the same day as TC chemotherapy, 3 hours from the end of TC administration. Cycles 2-4: Administered 24 hours after TC chemotherapy administration. Each cycle is 21 days.

Biological: Eflapegrastim; Drug: Docetaxel; Drug: Cyclophosphamide

Early Phase: Eflapegrastim @ 5 hours post TC

EXPERIMENTAL

Eflapegrastim (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg G-CSF). Supplied in prefilled single-use syringes for subcutaneous injection. Cycle 1: Administered on the same day as TC chemotherapy, 5 hours from the end of TC administration. Cycles 2-4: Administered 24 hours after TC chemotherapy administration. Each cycle is 21 days.

Biological: Eflapegrastim; Drug: Docetaxel; Drug: Cyclophosphamide

Expansion Phase: Eflapegrastim @ 30 mins post TC

EXPERIMENTAL

Eflapegrastim (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg G-CSF). Supplied in prefilled single-use syringes for subcutaneous injection. Cycles 1-4: Administered on the same day as TC chemotherapy, 30 minutes following the end of TC administration. Each cycle is 21 days.

Biological: Eflapegrastim; Drug: Docetaxel; Drug: Cyclophosphamide

Interventions

Eflapegrastim BIOLOGICAL

Administered in Cycle 1, 30 minutes after TC chemotherapy. Administered in Cycles 2-4, on day 2 of each cycle.

Early Phase: Eflapegrastim @ 30mins post TC

Docetaxel DRUG

75 mg/m\^2 IV infusion. Administered on Day 1 of each cycle.

Also known as: Taxotere

Early Phase: Eflapegrastim @ 3 hours post TC; Early Phase: Eflapegrastim @ 30mins post TC; Early Phase: Eflapegrastim @ 5 hours post TC; Expansion Phase: Eflapegrastim @ 30 mins post TC

Cyclophosphamide DRUG

600 mg/m\^2 IV infusion. Administered on Day 1 of each cycle.

Also known as: Cytoxan

Early Phase: Eflapegrastim @ 3 hours post TC; Early Phase: Eflapegrastim @ 30mins post TC; Early Phase: Eflapegrastim @ 5 hours post TC; Expansion Phase: Eflapegrastim @ 30 mins post TC

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Willing and capable of giving written Informed Consent and able to adhere to study drug dosing time and blood draw schedules
• New diagnosis of histologically confirmed early-stage breast cancer (ESBC), defined as operable Stage I to Stage IIIA breast cancer
• Candidate to receive adjuvant or neoadjuvant TC chemotherapy
• Age must be at least 18 years for the Early Phase, and between 18 to ≤55 years for the Expansion Phase
• ANC ≥1.5×10\^9/liter (L).
• Platelet count ≥100×10\^9/liter (L).
• Hemoglobin \>10 grams per deciliter (g/dL).
• Calculated creatinine clearance \>50 milliliter per minute (mL/min).
• Total bilirubin ≤1.5 milligrams per deciliter (mg/dL).
• Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≤2.5×upper limit of normal (ULN).
• Alkaline phosphatase ≤2.0×ULN.
• Eastern Cooperative Oncology Group (ECOG) ≤2
• Willing to practice 2 forms of contraceptives (1 must be a barrier method), from study entry through 30 days after last dose of study drug/ early discontinuation
• Negative urine pregnancy test within 30 days before randomization

You may not qualify if:

• Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix) or life-threatening disease
• Known sensitivity to Escherichia coli (E. coli) derived products
• Concurrent adjuvant cancer therapy other than the trial-specified therapies
• Locally recurrent/metastatic breast cancer
• Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within 3 months prior to the administration of study drug
• Receiving anti-infectives, has an underlying medical condition or other serious illness that would impair the ability to receive protocol-specified treatment
• Used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study
• Prior bone marrow or stem cell transplant
• Prior radiation therapy within 30 days prior to enrollment
• Major surgery within 30 days prior to enrollment
• Pregnant or breastfeeding

Sponsors & Collaborators

• Spectrum Pharmaceuticals, Inc: lead

Study Sites (8)

ACRC/ Arizona Clinical Research Center

Tucson, Arizona, 85715, United States

Location

Yuma Regional Medical Center Cancer Center

Yuma, Arizona, 85364, United States

Location

Pacific Cancer Medical Center

Anaheim, California, 92801, United States

Location

City of Hope

Long Beach, California, 90813, United States

Location

BRCR Medical Center, Inc.

Plantation, Florida, 33322, United States

Location

Bond & Steele Clinic, P.A.

Winter Haven, Florida, 33881, United States

Location

SCL Health Research Institute, Inc.

Billings, Montana, 59102, United States

Location

Mercy Health Youngstown

Youngstown, Ohio, 44501, United States

Location

MeSH Terms

Conditions

Neutropenia; Breast Neoplasms

Interventions

eflapegrastim; Docetaxel; Cyclophosphamide

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Considering two-phase study, where Expansion Phase followed Early Phase. The dosing within the Early Phase was in parallel assignment wherein participants were assigned to three arms in a 1:1:1 ratio. Patients completing Early Phase will enter the Expansion Phase to receive dosing in a single arm.

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: December 5, 2019
• Study Start: March 11, 2020
• Primary Completion: July 16, 2024
• Study Completion: August 16, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)